CAB+RPV LA for HIV
(IM-CAPABLE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to treat HIV using long-acting injections of two drugs, cabotegravir and rilpivirine, for individuals living far from an HIV care provider. The study aims to determine if these injections are practical and well-received by both patients and healthcare staff, while also assessing their impact on factors like HIV stigma and medication adherence. It is suitable for people with HIV who live outside the Omaha, Nebraska area and are beginning this injection treatment as part of their regular HIV care. Participants will complete questionnaires and participate in an interview over 15 months, and clinic staff will also share their experiences. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.
Do I need to stop my current medications for the CAB+RPV LA trial?
The trial information does not specify whether you need to stop your current medications. It's best to discuss this with your healthcare provider to understand how your current treatment might interact with the trial.
What prior data suggests that CAB+RPV LA is safe for people living with HIV?
Research shows that the combination treatment of cabotegravir and rilpivirine as long-acting injections (CAB+RPV LA) is generally safe for people with HIV. The most common side effects include reactions at the injection site, such as redness or swelling, which are usually mild and resolve on their own.
Studies have found that these injections are well-tolerated compared to standard oral treatments, with no major safety issues reported. Some participants have switched to CAB+RPV LA from other HIV treatments and found it equally effective and safe.
The FDA has already approved this treatment for HIV, providing extra reassurance about its safety. While every medication can have side effects, evidence so far suggests that CAB+RPV LA is safe for use in people.12345Why are researchers excited about this trial?
Researchers are excited about CAB+RPV LA for people with HIV because it offers a long-acting injectable option, which is a big shift from the traditional daily oral medications like tenofovir/emtricitabine-based therapies. This treatment combines cabotegravir (CAB) and rilpivirine (RPV) into an injectable form that only needs to be administered once every month or even every two months, reducing the pill burden and potentially improving adherence. Unlike the standard treatment regimens, which require daily intake, this approach aims to make it easier for patients to maintain their treatment schedule, especially those living in non-metropolitan areas with less frequent access to healthcare facilities.
What evidence suggests that CAB+RPV LA is effective for HIV?
Research shows that cabotegravir plus rilpivirine long-acting (CAB+RPV LA) injections effectively treat HIV. Studies have found that this treatment controls the virus as well as daily HIV pills. In this trial, participants receiving care at the University of Nebraska Medical Center (UNMC) Specialty Care Center who live outside the Omaha metropolitan area may choose to start CAB+RPV LA as part of their clinical care. Participants have reported high satisfaction with this treatment, noting it improves their experience compared to daily pills. The data indicates that the treatment is not only effective but also popular with patients, who experience fewer concerns about adherence and stigma. Overall, CAB+RPV LA offers a promising alternative to traditional daily HIV medications.46789
Who Is on the Research Team?
Nada Fadul, MD
Principal Investigator
University of Nebraska
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive CAB+RPV LA injections as part of regular medical care for HIV, involving completing questionnaires and interviews
Follow-up
Participants are monitored for safety and effectiveness after treatment, including viral suppression and treatment satisfaction
What Are the Treatments Tested in This Trial?
Interventions
- Cabotegravir + Rilpivirine
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Staff at the University of Nebraska Medical Center (UNMC) Specialty Care Center or the Nebraska Medicine Grand Island clinic who provide HIV-related care and are involved in this study.
Participants receiving care at the University of Nebraska Medical Center (UNMC) Specialty Care Center who live outside of the Omaha metropolitan area and who choose to start CAB+RPV LA as part of clinical care.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Nebraska
Lead Sponsor
ViiV Healthcare
Industry Sponsor
Dr. Harmony Garges
ViiV Healthcare
Chief Medical Officer
MD
Deborah Waterhouse
ViiV Healthcare
Chief Executive Officer since 2017
Bachelor's degree in Business Administration
Citations
Clinical Outcomes and Perspectives of People With Human ...
Participants receiving long-acting cabotegravir plus rilpivirine experienced high rates of virologic suppression and a low rate of ...
Long-Term Real-World Use of Cabotegravir/Rilpivirine
Despite increasing use of LA-CAB/RPV, long-term real-world data on durability, adherence, and virological outcomes remain limited to 2 years.
3.
viivhealthcare.com
viivhealthcare.com/hiv-news-and-media/news/press-releases/2025/july/long-acting-injectables-for-hiv-at-ias-2025/ViiV Healthcare presents new data demonstrating positive ...
24-month outcomes of cabotegravir+rilpivirine long-acting every 2 months in a real‑world setting: effectiveness, adherence to injections, and ...
Efficacy and safety of switching to long-acting cabotegravir ...
Mean (SD) HIVTSQs treatment satisfaction scores of Japanese participants showed greater improvement from baseline to Month 12 in the CAB+RPV LA group (+6.25 [ ...
Patient-reported outcomes in clinical trials assessing the ...
Results: Findings reveal that CAB + RPV-LA maintains high levels of viral suppression comparable to daily ART while improving patient ...
Safety, Tolerability, and Metabolic Effects of Long-Acting ...
Clinical trial data suggest that LA CAB/RPV is generally safe and well tolerated. The most common side effects were injection site reactions, ...
Safety and efficacy of long-acting cabotegravir/rilpivirine ...
This systematic review and meta-analysis compare the safety and efficacy of LAA versus standard oral treatment (SOT) for HIV.
NCT03299049 | Efficacy, Safety and Tolerability Study of ...
This Antiretroviral Therapy as Long Acting Suppression every 2 Months (ATLAS-2M) study is designed to demonstrate the non-inferior antiviral activity and ...
9.
aidsetc.org
aidsetc.org/blog/hiv-meds-updates-long-acting-injectable-therapy-cabotegravir-rilpivirineHIV Meds Updates - Long-acting Injectable Therapy
At the International AIDS Society 2021 meeting, investigators presented week 124 efficacy and safety data on the CAB+RPV arm of the study.
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